One of my greatest fears as someone who lives with Type 1 diabetes, is not waking up because of a Low blood sugar. Local paramedics have made multiple trips to my home because of overnight Lows that have resulted from an imbalance in my blood sugars, issues that have occurred without any warning despite all the management care that I take each day and night. Even with the multiple blood tests, meal management, and accurate insulin dosage, Low blood sugars happen and have dropped me so low that I am not able to wake up or function on my own. They have caused me to thrash and even become violent, hallucinating and trying to harm my wife as she tries to get more fast-acting sugar into my system to counter this hypoglycemia. Both children and adults with Type 1 diabetes have died as a result of these overnight hypoglycemic events, and even those happening during the daytime hours, causing them to lose awareness suddenly without warning. One way to prevent these tragedies and potential risk would be a Low Glucose Suspend, an option that is currently available on insulin pumps outside of the United States. These work effectively and save lives, however this is not available in the U.S. because of the FDA’s hesitation. Our A1c tests are not perfect, and are simply one resource in a very large and ever-expanding tool box that we use to manage our diabetes efficiently and practically. Living with diabetes is preferable to dying because of diabetes, something that is more likely now as a result of not having this Low Glucose Suspend capability. As a country, our current regulatory system preventing this life-saving option means we are behind the eight ball on this technology and losing innovation and dollars to other places globally that have this Low Glucose Suspend available. I’m hopeful that the FDA develops guidelines bringing us more in line with what’s available worldwide, and also aids in the development of future innovations that will save lives.
Michael W. Hoskins - Comment
This is comment on Notice
Draft Guidance for Industry and Staff; Availability: Content of Investigational Device Exemption and Premarket Approval Applications for Low Glucose Suspend Device Systems
View Comment
Related Comments
View AllPublic Submission Posted: 09/23/2011 ID: FDA-2011-D-0464-0004
Sep 20,2011 11:59 PM ET
Public Submission Posted: 09/23/2011 ID: FDA-2011-D-0464-0006
Sep 20,2011 11:59 PM ET
Public Submission Posted: 09/23/2011 ID: FDA-2011-D-0464-0007
Sep 20,2011 11:59 PM ET
Public Submission Posted: 09/23/2011 ID: FDA-2011-D-0464-0008
Sep 20,2011 11:59 PM ET
Public Submission Posted: 09/23/2011 ID: FDA-2011-D-0464-0009
Sep 20,2011 11:59 PM ET